Prescription drug · BLA
Entyvio (vedolizumab) NDC 64764-300
Vedolizumab 300 mg/5mL · Injection, Powder, Lyophilized, For solution · Intravenous · Takeda Pharmaceuticals America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64764-300-20 | 64764030020 | 1 VIAL, SINGLE-DOSE in 1 CARTON (64764-300-20) / 5 mL in 1 VIAL, SINGLE-DOSEMarketed from May 20, 2014 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Entyvio
- Generic name (nonproprietary)
- vedolizumab
- Active ingredients
- Vedolizumab — 300 mg/5mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125476
- Marketing start
- Listing expires
- Other FDA classes
- Integrin Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 64764-300_266293d6-dd28-4e38-81c2-4f518d95ef5dSPL ID 266293d6-dd28-4e38-81c2-4f518d95ef5dSPL set ID 6e94621c-1a95-4af9-98d1-52b9e6f1949cRxCUI 1538137, 1538142, 2667332, 2667336, 2667339, 2667342UNII 9RV78Q2002
- Pharmacologic class
- Integrin Receptor Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeMed-Code curated
J3380 — Injection, vedolizumab, 1 mg
Billing unit: 1 mg. Units on the claim = dose given ÷ 1 mg.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N464764030020followed by a unit qualifier and the quantityPackage 64764-0300-20. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
ENTYVIO is indicated in adults for the treatment of: moderately to severely active ulcerative colitis (UC). moderately to severely active Crohn's disease (CD). ENTYVIO is an integrin receptor antagonist indicated in adults for the treatment of: moderately to severely active ulcerative colitis (UC). ( 1 ) moderately to severely active Crohn's disease (CD). ( 1 )
Excerpt only. Read the full label for complete information.